Cost-effectiveness of behavioral activation compared to treatment as usual for depressed older adults in primary care: A cluster randomized controlled trial.

INTRODUCTION: Depression in older adults is associated with decreased quality of life and increased utilization of healthcare services. Behavioral activation (BA) is an effective treatment for late-life depression, but the cost-effectiveness compared to treatment as usual (TAU) is unknown. METHODS: An economic evaluation was performed alongside a cluster randomized controlled multicenter trial including 161 older adults (≥65 years) with moderate to severe depressive symptoms (PHQ-9 ≥ 10). Outcome measures were depression (response on the QIDS-SR), quality-adjusted life-years (QALYs) and societal costs. Missing data were imputed using multiple imputation. Cost and effect differences were estimated using bivariate linear regression models, and statistical uncertainty was estimated with bootstrapping. Cost-effectiveness acceptability curves showed the probability of cost-effectiveness at different ceiling ratios. RESULTS: Societal costs were statistically non-significantly lower in BA compared to TAU (mean difference (MD) -€485, 95 % CI -3861 to 2792). There were no significant differences in response on the QIDS-SR (MD 0.085, 95 % CI -0.015 to 0.19), and QALYs (MD 0.026, 95 % CI -0.0037 to 0.055). On average, BA was dominant over TAU (i.e., more effective and less expensive), although the probability of dominance was only 0.60 from the societal perspective and 0.85 from the health care perspective for both QIDS-SR response and QALYs. DISCUSSION: Although the results suggest that BA is dominant over TAU, there was considerable uncertainty surrounding the cost-effectiveness estimates which precludes firm conclusions.

What are the determinants of older people adopting communicative e-health services: a meta-ethnography.

BACKGROUND: Gradually, society has shifted more services online, with COVID-19 highlighting digital inequalities in access to services such as healthcare. Older adults can experience such digital inequalities, yet this group is also more likely to need medical appointments, compared to younger people. With the growing digitalisation of healthcare, it is increasingly important to understand how older people can best use communicative e-health services to interact with healthcare services. This is especially if older adults are to access, and actively interact with health professionals/clinicians due to their general health decline. This review aims to synthesise older adults' experiences and perceptions of communicative e-health services and, in turn, identify barriers and facilitators to using communicative e-health services. METHODS: A meta-ethnography was conducted to qualitatively synthesise literature on older adults' experiences of using communicative e-health services. A systematic search, with terms relating to 'older adults', 'e-health', 'technology', and 'communication', was conducted on six international databases between January 2014 and May 2022. The search yielded a total of 10 empirical studies for synthesis. RESULTS: The synthesis resulted in 10 themes that may impact older adults' perceptions and/or experiences of using communicative e-health services. These were: 1) health barriers, 2) support networks, 3) application interface/design, 4) digital literacy, 5) lack of awareness, 6) online security, 7) access to digital devices and the internet, 8) relationship with healthcare provider(s), 9) in-person preference and 10) convenience. These themes interlink with each other. CONCLUSION: The findings suggest older adults' experiences and perceptions of communicative e-health services are generally negative, with many reporting various barriers to engaging with online services. However, many of these negative experiences are related to limited support networks and low digital literacy, along with complicated application interfaces. This supports previous literature identifying barriers and facilitators in which older adults experience general technology adoption and suggests a greater emphasis is needed on providing support networks to increase the adoption and usage of communicative e-health services.

The Healthy Hearts Project: Development and evaluation of a website for cardiovascular risk assessment and visualisation and self-management through healthy lifestyle goal-setting.

Materially deprived communities in the UK have excess morbidity and mortality from cardiovascular disease (CVD) but are less likely to engage with formal care pathways. Community engagement and e-health may be more effective ways to promote risk-reducing lifestyle change. The "Healthy Hearts Project" website was designed for use by community health workers (CHWs) for cardiovascular risk assessment and lifestyle goal setting, or for independent use by community members. This paper describes the website's development and evaluation. The website was developed using interactive wire frame prototypes in a user-led approach. Qualitative evaluation of the completed website's usability and acceptability was conducted using the "Thinking Aloud" method in a purposive sample of 10 participants (one voluntary sector employee, three CHWs, two community members and four healthcare professionals). Thinking Aloud interview transcripts were thematically analysed using an inductive approach. A separate quantitative evaluation of usability and the effect of using the website on CVD knowledge and beliefs was conducted. A random sample of 134 participants, recruited using the online platform Prolific, completed the "Attitudes and Beliefs About Cardiovascular Disease" (ABCD) questionnaire before and after using the website, along with the System Usability Scale (SUS). Qualitative evaluation-Four key themes were identified: 1) Website functionality and design-participants generally found the website easy to use and understood the risk communication graphics and the feedback and goal-setting features,; 2) Inclusivity and representation-most participants considered the website inclusive of a range of users/cultures; 3) Language and comprehension-participants found the language used easy to understand but suggested reducing the amount of text; 4) Motivation and barriers to change-participants liked the personalized feedback and empowerment offered by goal-setting but commented on the need for self-motivation. Quantitative evaluation-The mean score across all domains of the ABCD questionnaire (from 2.99 to 3.11, p<0.001) and in the sub-domains relating to attitudes and beliefs around healthy eating and exercise increased after using the website. The mean(sd) score on the SUS was 77.5 (13.5). The website's usability was generally rated well by both quantitative and qualitative measures, and measures of CVD knowledge improved after use. A number of general recommendations for the design of eHealth behaviour change tools are made based on participants' suggestions to improve the website.

Behavioural Activation versus Treatment as Usual for Depressed Older Adults in Primary Care: A Pragmatic Cluster-Randomised Controlled Trial.

INTRODUCTION: Effective non-pharmacological treatment options for depression in older adults are lacking. OBJECTIVE: The effectiveness of behavioural activation (BA) by mental health nurses (MHNs) for depressed older adults in primary care compared with treatment as usual (TAU) was evaluated. METHODS: In this multicentre cluster-randomised controlled trial, 59 primary care centres (PCCs) were randomised to BA and TAU. Consenting older (≥65 years) adults (n = 161) with clinically relevant symptoms of depression (PHQ-9 ≥ 10) participated. Interventions were an 8-week individual MHN-led BA programme and unrestricted TAU in which general practitioners followed national guidelines. The primary outcome was self-reported depression (QIDS-SR16) at 9 weeks and 3, 6, 9, and 12-month follow-up. RESULTS: Data of 96 participants from 21 PCCs in BA and 65 participants from 16 PCCs in TAU, recruited between July 4, 2016, and September 21, 2020, were included in the intention-to-treat analyses. At post-treatment, BA participants reported significantly lower severity of depressive symptoms than TAU participants (QIDS-SR16 difference = -2.77, 95% CI = -4.19 to -1.35), p < 0.001; between-group effect size = 0.90; 95% CI = 0.42-1.38). This difference persisted up to the 3-month follow-up (QIDS-SR16 difference = -1.53, 95% CI = -2.81 to -0.26, p = 0.02; between-group effect size = 0.50; 95% CI = 0.07-0.92) but not up to the 12-month follow-up [QIDS-SR16 difference = -0.89 (-2.49 to 0.71)], p = 0.28; between-group effect size = 0.29 (95% CI = -0.82 to 0.24). CONCLUSIONS: BA led to a greater symptom reduction of depressive symptoms in older adults, compared to TAU in primary care, at post-treatment and 3-month follow-up, but not at 6- to 12-month follow-up.

The Pre-Implementation Phase of a Project Seeking to Deliver a Community-Based CVD Prevention Intervention (SPICES-Sussex): A Qualitative Study Exploring Views and Experience Relating to Intervention Development.

BACKGROUND.: Community-led health care interventions may be an effective way to tackle cardiovascular disease (CVD) risk factors, especially in materially deprived communities where health care resources are stretched and engagement with institutions is often low. To do so effectively and equitably, interventions might be developed alongside community members through community engagement. OBJECTIVES.: The aim of this project was to carry out stakeholder mapping and partnership identification and to understand the views, needs, experiences of community members who would be involved in later stages of a community-based CVD prevention intervention's development and implementation. METHODS.: Stakeholder mapping was carried out to identify research participants in three communities in Sussex, United Kingdom. A qualitative descriptive approach was taken during the analysis of focus groups and interviews with 47 participants. FINDINGS.: Three themes were highlighted related to intervention design (a) Management: the suitability of the intervention for the community, management of volunteers, and communication; (b) Logistics: the structure and design of the intervention; and (c) Sociocultural issues, the social and cultural expectations/experiences of participants and implementers. CONCLUSIONS.: Study participants were open and willing to engage in the planned community-based intervention, particularly in elements of co-design and community-led delivery. They also highlighted the importance of sociocultural factors. Based on the findings, we developed recommendations for intervention design which included (but were not limited to): (a) a focus on a bottom-up approach to intervention design, (b) the recruitment of skilled local volunteers, and (c) the importance of fun and simplicity.

Assessing the Impact of EQ-5D Country-specific Value Sets on Cost-utility Outcomes.

PURPOSE: To assess the impact of EQ-5D country-specific value sets on cost-utility outcomes. METHODS: Data from 2 randomized controlled trials on low back pain (LBP) and depression were used. 3L value sets were identified from the EuroQol Web site. A nonparametric crosswalk was employed for each tariff to obtain the likely 5L values. Differences in quality-adjusted life years (QALYs) between countries were tested using paired t tests, with United Kingdom as reference. Cost-utility outcomes were estimated for both studies and both EQ-5D versions, including differences in QALYs and cost-effectiveness acceptability curves. RESULTS: For the 3L, QALYs ranged between 0.650 (Taiwan) and 0.892 (United States) in the LBP study and between 0.619 (Taiwan) and 0.879 (United States) in the depression study. In both studies, most country-specific QALY estimates differed statistically significantly from that of the United Kingdom. Incremental cost-effectiveness ratios ranged between &OV0556;2044/QALY (Taiwan) and &OV0556;5897/QALY (Zimbabwe) in the LBP study and between &OV0556;38,287/QALY (Singapore) and &OV0556;96,550/QALY (Japan) in the depression study. At the NICE threshold of &OV0556;23,300/QALY (≈£20,000/QALY), the intervention's probability of being cost-effective versus control ranged between 0.751 (Zimbabwe) and 0.952 (Taiwan) and between 0.230 (Canada) and 0.396 (Singapore) in the LBP study and depression study, respectively. Similar results were found for the 5L, with extensive differences in ICERs and moderate differences in the probability of cost-effectiveness. CONCLUSIONS: This study indicates that the use of different EQ-5D country-specific value sets impacts on cost-utility outcomes. Therefore, to account for the fact that health state preferences are affected by sociocultural differences, relevant country-specific value sets should be used.

A brief cognitive behavioural intervention is cost-effective for primary care patients with medically unexplained physical symptoms compared to usual care.

OBJECTIVE: To assess the cost-effectiveness of a brief cognitive behavioural intervention for patients with medically unexplained physical symptoms (MUPS) provided by a mental health nurse practitioner (MHNP) in primary care in comparison with usual care. METHODS: We performed an economic evaluation from a societal perspective alongside a cluster randomised controlled trial with 12 months follow-up. The primary outcome was quality-adjusted life-years (QALYs). Secondary outcomes were the RAND-36 physical component summary score (PCS), somatic symptom severity (Patient Health Questionnaire (PHQ-15), and anxiety and depression symptoms (Hospital Anxiety and Depression Scale (HADS)). Missing data were imputed using multiple imputation. We used non-parametric bootstrapping to estimate statistical uncertainty. The bootstrapped cost-effect pairs were used to estimate cost-effectiveness planes and cost-effectiveness acceptability curves. RESULTS: Mean total costs in the intervention group were significantly lower than in the usual care group (mean difference - 2300€, 95% CI -3257 to -134). The mean difference in QALYs was 0.01 (95% CI -0.01 to 0.04), in PCS 2.46 (95% CI 1.44 to 3.47), in PHQ-15 -0.26 (95% CI -0.81 to 0.28), and in HADS -0.07 (-0.81 to 0.67). At a willingness to pay of 0 € per additional unit of effect, the probability of the intervention being cost-effective was 0.93 for QALYs and 0.92 for PCS, PHQ-15 and HADS scores. CONCLUSION: Our intervention is cost-effective compared to usual care for patients with MUPS. Implementation of the intervention has the potential to result in a significant decline in costs. However, large scale implementation would require increased deployment of MHNPs.

A protocol paper: community engagement interventions for cardiovascular disease prevention in socially disadvantaged populations in the UK: an implementation research study.

Background: Cardiovascular disorders (CVD) are the single greatest cause of mortality worldwide. In the UK, the National Health Service (NHS) has launched an initiative of health checks over and above current care to tackle CVD. However, the uptake of Health Checks is poor in disadvantaged communities. This protocol paper sets out a UK-based study (Sussex and Nottingham) aiming to co-produce a community delivered CVD risk assessment and coaching intervention to support community members to reduce their risk of CVD.The overall aim of the project is to implement a tailored-to-context community engagement (CE) intervention on awareness of CVD risks in vulnerable populations in high, middle and low-income countries. The specific objectives of the study are to enhance stakeholder' engagement; to implement lifestyle interventions for cardiovascular primary prevention, in disadvantaged populations and motivate uptake of NHS health checks. Methods: This study uses both qualitative and quantitative methods in three phases of evaluation, including pre-, per- and post-implementation. To ensure contextual appropriateness the 'Scaling-up Packages of Interventions for Cardiovascular disease prevention in selected sites in Europe and Sub-Saharan Africa: An implementation research' (SPICES) project will organize a multi-component community-engagement intervention. For the qualitative component, the pre-implementation phase will involve a contextual assessment and stakeholder mapping, exploring potentials for CVD risk profiling strategies and led by trained Community Health Volunteers (CHV) to identify accessibility and acceptability. The per-implementation phase will involve healthy lifestyle counselling provided by CHVs and evaluation of the outcome to identify fidelity and scalability. The post-implementation phase will involve developing sustainable community-based strategies for CVD risk reduction. All three components will include a process evaluation. A stepped wedge cluster randomised trial of the roll out will focus on implementation outcomes including uptake and engagement and changes in risk profiles. The quantitative component includes pre and post-intervention surveys. The theory of the socio-ecological framework will be applied to analyse the community engagement approach. Discussion: Based on the results ultimately a sustainable community engagement-based strategy for the primary prevention of CVD risk will be developed to enhance the performance of NHS health care in the UK. The Trial Registration number is ISRCTN68334579.

Supported self-help to prevent relapse or recurrence of depression: Who benefits most?

BACKGROUND: This study aimed to identify subgroups for whom supported self-help preventive cognitive therapy (S-PCT) is more (cost)effective than treatment as usual (TAU) in preventing relapse and recurrence of major depression. METHODS: We conducted a randomized controlled trial in which 248 remitted, recurrently depressed participants were randomized to S-PCT (n = 124) or TAU (n = 124). Clinical outcome was relapse or recurrence of major depressive disorder (SCID-I). We tested the moderating effects on relapse or recurrence of age, gender, education level, residual depressive symptoms, number of previous episodes, age of onset, antidepressant medication, somatization, and self-efficacy with logistic regression analyses adjusted for baseline values of depressive symptoms. We examined moderating effects on costs using linear regression analyses adjusted for baseline costs. A stratified cost-effectiveness analysis was performed to tease out differences in cost-effectiveness between subgroups. RESULTS: We found no moderating effect on relapse or recurrence for any of the potential moderators. For costs, the number of previous depressive episodes was identified as a moderator. At a willingness-to-pay of 16,000€, the probability that S-PCT was cost-effective compared to TAU was 95% for participants with 2-3 episodes and 11% for participants with ≥4 episodes. LIMITATIONS: Participants and counselors were not blinded. The study was primarily designed to assess the (cost)effectiveness of S-PCT and not to conduct moderation analyses. CONCLUSIONS: S-PCT was effective in preventing relapse or recurrence of depressive disorders in a broad range of participants, but is more likely to be cost-effective in participants with 2-3 episodes than ≥4 episodes. This indicates that S-PCT can best be offered to participants with fewer previous depressive episodes.

An implementation science study to enhance cardiovascular disease prevention in Mukono and Buikwe districts in Uganda: a stepped-wedge design.

BACKGROUND: Uganda is experiencing a shift in major causes of death with cases of stroke, heart attack, and heart failure reportedly on the rise. In a study in Mukono and Buikwe in Uganda, more than one in four adults were reportedly hypertensive. Moreover, very few (36.5%) reported to have ever had a blood pressure measurement. The rising burden of CVD is compounded by a lack of integrated primary health care for early detection and treatment of people with increased risk. Many people have less access to effective and equitable health care services which respond to their needs. Capacity gaps in human resources, equipment, and drug supply, and laboratory capabilities are evident. Prevention of risk factors for CVD and provision of effective and affordable treatment to those who require it prevent disability and death and improve quality of life. The aim of this study is to improve health profiles for people with intermediate and high risk factors for CVD at the community and health facility levels. The implementation process and effectiveness of interventions will be evaluated. METHODS: The overall study is a type 2-hybrid stepped-wedge (SW) design. The design employs mixed methods evaluations with incremental execution and adaptation. Sequential crossover take place from control to intervention until all are exposed. The study will take place in Mukono and Buikwe districts in Uganda, home to more than 1,000,000 people at the community and primary healthcare facility levels. The study evaluation will be guided by; 1) RE-AIM an evaluation framework and 2) the CFIR a determinant framework. The primary outcomes are implementation - acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, coverage, and sustainability. DISCUSSION: The study is envisioned to provide important insight into barriers and facilitators of scaling up CVD prevention in a low income context. This project is registered at the ISRCTN Registry with number ISRCTN15848572. The trial was first registered on 03/01/2019.

A supported self-help for recurrent depression in primary care; An economic evaluation alongside a multi-center randomised controlled trial.

BACKGROUND: Major depression is a prevalent mental disorder with a high risk of relapse or recurrence. Only few studies have focused on the cost-effectiveness of interventions aimed at the prevention of relapse or recurrence of depression in primary care. AIM: To evaluate the cost-effectiveness of a supported Self-help Preventive Cognitive Therapy (S-PCT) added to treatment-as-usual (TAU) compared with TAU alone for patients with a history of depression, currently in remission. METHODS: An economic evaluation alongside a multi-center randomised controlled trial was performed (n = 248) over a 12-month follow-up. Outcomes included relapse or recurrence of depression and quality-adjusted-life-years (QALYs) based on the EuroQol-5D. Analyses were performed from both a societal and healthcare perspective. Missing data were imputed using multiple imputations. Uncertainty was estimated using bootstrapping and presented using the cost-effectiveness plane and the Cost-Effectiveness Acceptability Curve (CEAC). Cost estimates were adjusted for baseline costs. RESULTS: S-PCT statistically significantly decreased relapse or recurrence by 15% (95%CI 3;28) compared to TAU. Mean total societal costs were €2,114 higher (95%CI -112;4261). From a societal perspective, the ICER for relapse or recurrence was 13,515. At a Willingness To Pay (WTP) of 22,000 €/recurrence prevented, the probability that S-PCT is cost-effective, in comparison with TAU, is 80%. The ICER for QALYs was 63,051. The CEA curve indicated that at a WTP of 30,000 €/QALY gained, the probability that S-PCT is cost-effective compared to TAU is 21%. CONCLUSIONS: Though ultimately depending on the WTP of decision makers, we expect that for both relapse or recurrence and QALYs, S-PCT cannot be considered cost-effective compared to TAU.

Increasing socioeconomic gap between the young and old: temporal trends in health and overall deprivation in England by age, sex, urbanity and ethnicity, 2004-2015.

BACKGROUND: At a low geographical level, little is known about the associations between population characteristics and deprivation, and their trends, which would be directly affected by the house market, labour pressures and government policies. We describe temporal trends in health and overall deprivation in England by age, sex, urbanity and ethnicity. METHODS: Repeated cross-sectional whole population study for England, 2004-2015, at a low geographical level (average 1500 residents). We calculated weighted medians of the Index of Multiple Deprivation (IMD) for each subgroup of interest. RESULTS: Over time, we observed increases in relative deprivation for people aged under 30, and aged 30-59, while median deprivation decreased for those aged 60 or over. Subgroup analyses indicated that relative overall deprivation was consistently higher for young adults (aged 20-29) and infants (aged 0-4), with increases in deprivation for the latter. Levels of overall deprivation in 2004 greatly varied by ethnicity, with the lowest levels observed for White British and the highest for Blacks. Over time, small reductions were observed in the deprivation gap between White British and all other ethnic groups. Findings were consistent across overall IMD and its health and disability subdomain, but large regional variability was also observed. CONCLUSIONS: Government policies, the financial crisis of 2008, education funding and the increasing cost of houses relative to real wages are important parameters in interpreting our findings. Socioeconomic deprivation is an important determinant of health and the inequalities this work highlights may have significant implications for future fiscal and healthcare policy.

Chronic morbidity, deprivation and primary medical care spending in England in 2015-16: a cross-sectional spatial analysis.

BACKGROUND: Primary care provides the foundation for most modern health-care systems, and in the interests of equity, it should be resourced according to local need. We aimed to describe spatially the burden of chronic conditions and primary medical care funding in England at a low geographical level, and to measure how much variation in funding is explained by chronic condition prevalence and other patient and regional factors. METHODS: We used multiple administrative data sets including chronic condition prevalence and management data (2014/15), funding for primary-care practices (2015-16), and geographical and area deprivation data (2015). Data were assigned to a low geographical level (average 1500 residents). We investigated the overall morbidity burden across 19 chronic conditions and its regional variation, spatial clustering and association with funding and area deprivation. A linear regression model was used to explain local variation in spending using patient demographics, morbidity, deprivation and regional characteristics. RESULTS: Levels of morbidity varied within and between regions, with several clusters of very high morbidity identified. At the regional level, morbidity was modestly associated with practice funding, with the North East and North West appearing underfunded. The regression model explained 39% of the variability in practice funding, but even after adjusting for covariates, a large amount of variability in funding existed across regions. High morbidity and, especially, rural location were very strongly associated with higher practice funding, while associations were more modest for high deprivation and older age. CONCLUSIONS: Primary care funding in England does not adequately reflect the contemporary morbidity burden. More equitable resource allocation could be achieved by making better use of routinely available information and big data resources. Similar methods could be deployed in other countries where comparable data are collected, to identify morbidity clusters and to target funding to areas of greater need.

Geographical epidemiology of health and overall deprivation in England, its changes and persistence from 2004 to 2015: a longitudinal spatial population study.

BACKGROUND: Socioeconomic deprivation is a key determinant for health. In England, the Index of Multiple Deprivation (IMD) is a widely used composite measure of deprivation. However, little is known about its spatial clustering or persistence across time. METHODS: Data for overall IMD and its health domain were analysed for 2004-2015 at a low geographical area (average of 1500 people). Levels and temporal changes were spatially visualised for the whole of England and its 10 administrative regions. Spatial clustering was quantified using Moran's I, correlations over time were quantified using Pearson's r. RESULTS: Between 2004 and 2015 we observed a strong persistence for both overall (r=0.94) and health-related deprivation (r=0.92). At the regional level, small changes were observed over time, but with areas slowly regressing towards the mean. However, for the North East, North West and Yorkshire, where health-related deprivation was the highest, the decreasing trend in health-related deprivation reversed and we noticed increases in 2015. Results did not support our hypothesis of increasing spatial clustering over time. However, marked regional variability was observed in both aggregate deprivation outcomes. The lowest autocorrelation was seen in the North East and changed very little over time, while the South East had the highest autocorrelation at all time points. CONCLUSIONS: Overall and health-related deprivation patterns persisted in England, with large and unchanging health inequalities between the North and the South. The spatial aspect of deprivation can inform the targeting of health and social care interventions, particularly in areas with high levels of deprivation clustering.

Illness burden and physical outcomes associated with collaborative care in patients with comorbid depressive disorder in chronic medical conditions: A systematic review and meta-analysis.

OBJECTIVE: Collaborative care (CC) improves depressive symptoms in people with comorbid depressive disorder in chronic medical conditions, but its effect on physical symptoms has not yet systematically been reviewed. This study aims to do so. METHODS: Systematic review and meta-analysis was conducted using PubMed, the Cochrane Library, and the European and US Clinical Trial Registers. Eligible studies included randomized controlled trials (RCTs) of CC compared to care as usual (CAU), in primary care and general hospital setting, reporting on physical and depressive symptoms as outcomes. Overall treatment effects were estimated for illness burden, physical outcomes and depression, respectively. RESULTS: Twenty RCTs were included, with N=4774 patients. The overall effect size of CC versus CAU for illness burden was OR 1.64 (95%CI 1.47;1.83), d=0.27 (95%CI 0.21;0.33). Best physical outcomes in CC were found for hypertension with comorbiddepression. Overall, depression outcomes were better for CC than for CAU. Moderator analyses did not yield statistically significant differences. CONCLUSIONS: CC is more effective than CAU in terms of illness burden, physical outcomes and depression, in patients with comorbid depression in chronic medical conditions. More research covering multiple medical conditions is needed. PROTOCOL REGISTRATION NUMBER: The protocol for this systematic review and meta-analysis has been registered at the International Prospective Register of Systematic Reviews (PROSPERO) on February 19th 2016: http://www.crd.york.ac.uk/PROSPERO/DisplayPDF.php?ID=CRD42016035553.

Behavioural activation by mental health nurses for late-life depression in primary care: a randomized controlled trial.

BACKGROUND: Depressive symptoms are common in older adults. The effectiveness of pharmacological treatments and the availability of psychological treatments in primary care are limited. A behavioural approach to depression treatment might be beneficial to many older adults but such care is still largely unavailable. Behavioural Activation (BA) protocols are less complicated and more easy to train than other psychological therapies, making them very suitable for delivery by less specialised therapists. The recent introduction of the mental health nurse in primary care centres in the Netherlands has created major opportunities for improving the accessibility of psychological treatments for late-life depression in primary care. BA may thus address the needs of older patients while improving treatment outcome and lowering costs.The primary objective of this study is to compare the effectiveness and cost-effectiveness of BA in comparison with treatment as usual (TAU) for late-life depression in Dutch primary care. A secondary goal is to explore several potential mechanisms of change, as well as predictors and moderators of treatment outcome of BA for late-life depression. METHODS/DESIGN: Cluster-randomised controlled multicentre trial with two parallel groups: a) behavioural activation, and b) treatment as usual, conducted in primary care centres with a follow-up of 52 weeks. The main inclusion criterion is a PHQ-9 score > 9. Patients are excluded from the trial in case of severe mental illness that requires specialized treatment, high suicide risk, drug and/or alcohol abuse, prior psychotherapy, change in dosage or type of prescribed antidepressants in the previous 12 weeks, or moderate to severe cognitive impairment. The intervention consists of 8 weekly 30-min BA sessions delivered by a trained mental health nurse. DISCUSSION: We expect BA to be an effective and cost-effective treatment for late-life depression compared to TAU. BA delivered by mental health nurses could increase the availability and accessibility of non-pharmacological treatments for late-life depression in primary care. TRIAL REGISTRATION: This study is retrospectively registered in the Dutch Clinical Trial Register NTR6013 on August 25th 2016.

The CIPRUS study, a nurse-led psychological treatment for patients with undifferentiated somatoform disorder in primary care: study protocol for a randomised controlled trial.

BACKGROUND: Up to a third of patients presenting medically unexplained physical symptoms in primary care may have a somatoform disorder, of which undifferentiated somatoform disorder (USD) is the most common type. Psychological interventions can reduce symptoms associated with USD and improve functioning. Previous research has either been conducted in secondary care or interventions have been provided by general practitioners (GPs) or psychologists in primary care. As efficiency and cost-effectiveness are imperative in primary care, it is important to investigate whether nurse-led interventions are effective as well. The aim of this study is to examine the effectiveness and cost-effectiveness of a short cognitive behavioural therapy (CBT)-based treatment for patients with USD provided by mental health nurse practitioners (MHNPs), compared to usual care. METHODS: In a cluster randomised controlled trial, 212 adult patients with USD will be assigned to the intervention or care as usual. The intervention group will be offered a short, individual CBT-based treatment by the MHNP in addition to usual GP care. The main goal of the intervention is that patients become less impaired by their physical symptoms and cope with symptoms in a more effective way. In six sessions patients will receive problem-solving treatment. The primary outcome is improvement in physical functioning, measured by the physical component summary score of the RAND-36. Secondary outcomes include health-related quality of life measured by the separate subscales of the RAND-36, somatization (PHQ-15) and symptoms of depression and anxiety (HADS). Problem-solving skills, health anxiety, illness perceptions, coping, mastery and working alliance will be assessed as potential mediators. Assessments will be done at 0, 2, 4, 8 and 12 months. An economic evaluation will be conducted from a societal perspective with quality of life as the primary outcome measure assessed by the EQ-5D-5L. Health care, patient and lost productivity costs will be assessed with the Tic-P. DISCUSSION: We expect that the intervention will improve physical functioning and is cost-effective compared to usual care. If so, more patients might successfully be treated in general practice, decreasing the number of referrals to specialist care. TRIAL REGISTRATION: Dutch Trial Registry, identifier: NTR4686 , Registered on 14 July 2014.

Utility scores for different health states related to depression: individual participant data analysis.

OBJECTIVES: Depression is associated with considerable impairments in health-related quality-of-life. However, the relationship between different health states related to depression severity and utility scores is unclear. The aim of this study was to evaluate whether utility scores are different for various health states related to depression severity. METHODS: We gathered individual participant data from ten randomized controlled trials evaluating depression treatments. The UK EQ-5D and SF-6D tariffs were used to generate utility scores. We defined five health states that were proposed from American Psychiatric Association and National Institute for Clinical Excellence guidelines: remission, minor depression, mild depression, moderate depression, and severe depression. We performed multilevel linear regression analysis. RESULTS: We included 1629 participants in the analyses. The average EQ-5D utility scores for the five health states were 0.70 (95% CI 0.67-0.73) for remission, 0.62 (95% CI 0.58-0.65) for minor depression, 0.57 (95% CI 0.54-0.61) for mild depression, 0.52 (95%CI 0.49-0.56) for moderate depression, and 0.39 (95% CI 0.35-0.43) for severe depression. In comparison with the EQ-5D, the utility scores based on the SF-6D were similar for remission (EQ-5D = 0.70 vs. SF-6D = 0.69), but higher for severe depression (EQ-5D = 0.39 vs. SF-6D = 0.55). CONCLUSIONS: We observed statistically significant differences in utility scores between depression health states. Individuals with less severe depressive symptoms had on average statistically significant higher utility scores than individuals suffering from more severe depressive symptomatology. In the present study, EQ-5D had a larger range of values as compared to SF-6D.

Non-fatal disease burden for subtypes of depressive disorder: population-based epidemiological study.

BACKGROUND: Major depression is the leading cause of non-fatal disease burden. Because major depression is not a homogeneous condition, this study estimated the non-fatal disease burden for mild, moderate and severe depression in both single episode and recurrent depression. All estimates were assessed from an individual and a population perspective and presented as unadjusted, raw estimates and as estimates adjusted for comorbidity. METHODS: We used data from the first wave of the second Netherlands-Mental-Health-Survey-and-Incidence-Study (NEMESIS-2, n = 6646; single episode Diagnostic and Statistical Manual (DSM)-IV depression, n = 115; recurrent depression, n = 246). Disease burden from an individual perspective was assessed as 'disability weight * time spent in depression' for each person in the dataset. From a population perspective it was assessed as 'disability weight * time spent in depression *number of people affected'. The presence of mental disorders was assessed with the Composite International Diagnostic Interview (CIDI) 3.0. RESULTS: Single depressive episodes emerged as a key driver of disease burden from an individual perspective. From a population perspective, recurrent depressions emerged as a key driver. These findings remained unaltered after adjusting for comorbidity. CONCLUSIONS: The burden of disease differs between the subtype of depression and depends much on the choice of perspective. The distinction between an individual and a population perspective may help to avoid misunderstandings between policy makers and clinicians.